Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study.

Content Provider	Europe PMC
Author	Khamashta, Munther Merrill, Joan T Werth, Victoria P Furie, Richard Kalunian, Kenneth Illei, Gabor G Drappa, Jorn Wang, Liangwei Greth, Warren
Copyright Year	2016
Abstract	ObjectivesThe efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled study (NCT01283139) of adults with moderate to severe active systemic lupus erythematosus (SLE).Methods431 patients were randomised and received monthly intravenous sifalimumab (200 mg, 600 mg or 1200 mg) or placebo in addition to standard-of-care medications. Patients were stratified by disease activity, interferon gene-signature test (high vs low based on the expression of four genes) and geographical region. The primary efficacy end point was the percentage of patients achieving an SLE responder index response at week 52.ResultsCompared with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end point (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%; 1200 mg 59.8%). Other improvements were seen in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (200 mg and 1200 mg monthly), Physician's Global Assessment (600 mg and 1200 mg monthly), British Isles Lupus Assessment Group-based Composite Lupus Assessment (1200 mg monthly), 4-point reductions in the SLE Disease Activity Index−2000 score and reductions in counts of swollen joints and tender joints. Serious adverse events occurred in 17.6% of patients on placebo and 18.3% of patients on sifalimumab. Herpes zoster infections were more frequent with sifalimumab treatment.ConclusionsSifalimumab is a promising treatment for adults with SLE. Improvement was consistent across various clinical end points, including global and organ-specific measures of disease activity.Trial registration numberNCT01283139; Results.
ISSN	00034967
Journal	Annals of the Rheumatic Diseases
Volume Number	75
PubMed Central reference number	PMC5099191
Issue Number	11
PubMed reference number	27009916
e-ISSN	14682060
DOI	10.1136/annrheumdis-2015-208562
Language	English
Publisher	BMJ Publishing Group
Publisher Date	2016-03-23
Publisher Place	BMA House, Tavistock Square, London, WC1H 9JR
Access Restriction	Open
Rights License	This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Subject Keyword	Systemic Lupus Erythematosus Treatment Autoimmune Diseases
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Biochemistry, Genetics and Molecular Biology Immunology Rheumatology